Drug Catalog - Product Detail
Ranolazine Tab ER 12HR 1000 MG 60 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50228-0424-60 | SCIEGEN PHARMACEUTICALS | 60 | 1000MG | TABLET |
PACKAGE FILES
Generic Name
RANOLAZINE
Substance Name
RANOLAZINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA211829
Description
11 DESCRIPTION Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N -(2,6- dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C 24 H 33 N 3 O 4 , a molecular weight of 427.54 g/mole, and the following structural formula: Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, hypromellose, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, Iron Oxide Yellow, and Iron Oxide Red; additional inactive ingredients for the 1000 mg tablet include hydroxypropyl methyl cellulose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin and Iron Oxide Yellow. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ranolazine extended-release tablets are supplied as film-coated, oblong-shaped, extended-release tablets in the following strengths: 500 mg tablets are peach, with “423” on one side and “SG” on the other side 1000 mg tablets are pale yellow, with “424” on one side and “SG” on the other side Ranolazine extended-release tablets 500 mg are available in: Bottle of 30 Tablets: NDC 50228-423-30 Bottle of 60 Tablets: NDC 50228-423-60 Bottle of 500 Tablets: NDC 50228-423-05 Ranolazine extended-release tablets 1000 mg are available in: Bottle of 30 Tablets: NDC 50228-424-30 Bottle of 60 Tablets: NDC 50228-424-60 Bottle of 500 Tablets: NDC 50228-424-05 Store at 25°C (77°F); with excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Indications & Usage
1 INDICATIONS AND USAGE Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 500 mg twice daily and increase to 1000 mg twice daily, based on clinical symptoms ( 2.1 ) 2.1 Dosing Information Initiate Ranolazine extended-release tablets dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take Ranolazine extended-release tablets with or without meals. Swallow Ranolazine extended-release tablets whole; do not crush, break, or chew. The maximum recommended daily dose of Ranolazine extended-release tablets is 1000 mg twice daily. If a dose of Ranolazine extended-release tablets is missed, take the prescribed dose at the next scheduled time; do not double the next dose. 2.2 Dose Modification Dose adjustments may be needed when Ranolazine extended-release tablets are taken in combination with certain other drugs [see Drug Interactions (7.1) ] . Limit the maximum dose of Ranolazine extended-release tablets to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of Ranolazine extended-release tablets with strong CYP3A inhibitors is contraindicated [see Contraindications (4) , Drug Interactions (7.1) ]. Use of P-gp inhibitors, such as cyclosporine, may increase exposure to Ranolazine extended-release tablets. Titrate Ranolazine extended-release tablets based on clinical response [see Drug Interactions (7.1) ].